Gout Drug May Help in Metabolic Syndrome

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Colchicine, used to suppress or prevent inflammation in gout and pericarditis, may have a role in treating metabolic syndrome, according to an NIH pilot study.

Colchicine inhibits the formation of the Nod-like Receptor Family Pyrin Domain Containing 3 (NLRP3) inflammasome, a key component in the obesity-associated inflammatory cascade. In a retrospective study, long-term colchicine treatment had glycemic benefit in patients with gout. Other research has suggested that suppressing NLRP3 could improve peripheral insulin resistance as well as β-cell insulin production. However, no randomized controlled trial had yet investigated colchicine’s long-term effects on glucose metabolism in adults with obesity and metabolic syndrome (MetS).

The NIH researchers enrolled 40 adults to receive either colchicine or placebo; 37 completed the 3-month study. Adherence was high in both groups.

Colchicine significantly reduced multiple markers of obesity-associated inflammation, including high sensitivity C-reactive protein and erythrocyte sedimentation rate. The colchicine group also had moderate but statistically significant reductions in white blood cell count, monocytes, neutrophils, and platelets, without significant effects on lymphocyte count.

Although colchicine’s effects on the primary outcome of insulin sensitivity were not significant, some of the secondary outcomes related to glucose homeostasis—eg, insulin resistance and fasting insulin—suggest colchicine treatment may improve hepatic insulin sensitivity. Moreover, the researchers say, a trend toward improvement in disposition index suggests that the drug might potentially delay the onset of diabetes in people at risk. 

While some small, short-term studies had suggested that colchicine might worsen metabolic variables by inhibiting insulin secretion, other recent retrospective studies found long-term colchicine use did not negatively affect insulin secretion or glycemic control. In this study, similarly, the researchers say, chronic colchicine use did not impair first-phase insulin response or insulin sensitivity, and other markers of metabolic health, such as hemoglobin A1c and cholesterol, were not significantly changed. However, the researchers acknowledge that their study may have been too small to confirm those differences, and say larger studies are warranted.

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Colchicine, used to suppress or prevent inflammation in gout and pericarditis, may have a role in treating metabolic syndrome, according to an NIH pilot study.
Colchicine, used to suppress or prevent inflammation in gout and pericarditis, may have a role in treating metabolic syndrome, according to an NIH pilot study.

Colchicine inhibits the formation of the Nod-like Receptor Family Pyrin Domain Containing 3 (NLRP3) inflammasome, a key component in the obesity-associated inflammatory cascade. In a retrospective study, long-term colchicine treatment had glycemic benefit in patients with gout. Other research has suggested that suppressing NLRP3 could improve peripheral insulin resistance as well as β-cell insulin production. However, no randomized controlled trial had yet investigated colchicine’s long-term effects on glucose metabolism in adults with obesity and metabolic syndrome (MetS).

The NIH researchers enrolled 40 adults to receive either colchicine or placebo; 37 completed the 3-month study. Adherence was high in both groups.

Colchicine significantly reduced multiple markers of obesity-associated inflammation, including high sensitivity C-reactive protein and erythrocyte sedimentation rate. The colchicine group also had moderate but statistically significant reductions in white blood cell count, monocytes, neutrophils, and platelets, without significant effects on lymphocyte count.

Although colchicine’s effects on the primary outcome of insulin sensitivity were not significant, some of the secondary outcomes related to glucose homeostasis—eg, insulin resistance and fasting insulin—suggest colchicine treatment may improve hepatic insulin sensitivity. Moreover, the researchers say, a trend toward improvement in disposition index suggests that the drug might potentially delay the onset of diabetes in people at risk. 

While some small, short-term studies had suggested that colchicine might worsen metabolic variables by inhibiting insulin secretion, other recent retrospective studies found long-term colchicine use did not negatively affect insulin secretion or glycemic control. In this study, similarly, the researchers say, chronic colchicine use did not impair first-phase insulin response or insulin sensitivity, and other markers of metabolic health, such as hemoglobin A1c and cholesterol, were not significantly changed. However, the researchers acknowledge that their study may have been too small to confirm those differences, and say larger studies are warranted.

Colchicine inhibits the formation of the Nod-like Receptor Family Pyrin Domain Containing 3 (NLRP3) inflammasome, a key component in the obesity-associated inflammatory cascade. In a retrospective study, long-term colchicine treatment had glycemic benefit in patients with gout. Other research has suggested that suppressing NLRP3 could improve peripheral insulin resistance as well as β-cell insulin production. However, no randomized controlled trial had yet investigated colchicine’s long-term effects on glucose metabolism in adults with obesity and metabolic syndrome (MetS).

The NIH researchers enrolled 40 adults to receive either colchicine or placebo; 37 completed the 3-month study. Adherence was high in both groups.

Colchicine significantly reduced multiple markers of obesity-associated inflammation, including high sensitivity C-reactive protein and erythrocyte sedimentation rate. The colchicine group also had moderate but statistically significant reductions in white blood cell count, monocytes, neutrophils, and platelets, without significant effects on lymphocyte count.

Although colchicine’s effects on the primary outcome of insulin sensitivity were not significant, some of the secondary outcomes related to glucose homeostasis—eg, insulin resistance and fasting insulin—suggest colchicine treatment may improve hepatic insulin sensitivity. Moreover, the researchers say, a trend toward improvement in disposition index suggests that the drug might potentially delay the onset of diabetes in people at risk. 

While some small, short-term studies had suggested that colchicine might worsen metabolic variables by inhibiting insulin secretion, other recent retrospective studies found long-term colchicine use did not negatively affect insulin secretion or glycemic control. In this study, similarly, the researchers say, chronic colchicine use did not impair first-phase insulin response or insulin sensitivity, and other markers of metabolic health, such as hemoglobin A1c and cholesterol, were not significantly changed. However, the researchers acknowledge that their study may have been too small to confirm those differences, and say larger studies are warranted.

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The VA vs HCV: Making a Deadly Disease a Memory

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The VA is “within striking distance” of eliminating the hepatitis C virus in all veterans “willing and able to be treated,” with the expectation that everyone eligible will be cured by late this year.

“This is terrific news,” said US Department of Veterans Affairs (VA) Secretary Robert Wilkie, noting that the VA is the largest single provider of hepatitis C virus (HCV) care in the US. “Diagnosing, treating, and curing hepatitis C virus infection among veterans has been a significant priority for VA.” According to the Review of Hepatitis C Virus Care within the Veterans Health Administration, published last month by the VA Office of Inspector General (OIG), the VA cares for more than 180,000 confirmed patients who are disproportionately affected by HCV infection, at rates about 3 times that of the national average.

As of March, nearly 116,000 veterans had started all-oral HCV medications. Almost 100,000 have completed treatment and are now cured. As an article in Forbes magazine pointed out, that is a story very different from the one reported just a few years earlier, when HCV treatment was out of reach for the tens of thousands of service members seriously ill with HCV, most of whom contracted it during blood transfusions in the Vietnam War.

The good news is due largely to the use of highly effective direct-acting antivirals (DAAs), which have revolutionized HCV treatment. Before 2014, HCV treatment required weekly interferon injections for up to a year, with low cure rates (35%-55%) and significant physical and psychiatric adverse effects (AEs), leading to frequent early discontinuation. Of the approximately 180,000 veterans in VA care at that time who had been diagnosed with chronic HCV infection, only 12,000 had been treated and cured. More than 30,000 had advanced liver disease.

In 2014, the VA launched an “aggressive program” to identify all undiagnosed veterans with HCV, link them to care, and offer them treatment with the new medications: sofosbuvir (Sovaldi) and simeprevir (Olysio). They have few AEs and can be administered once daily for as few as 8 weeks.

However, those drugs were incredibly expensive, prohibitively so for many people. Sovaldi cost $1,000 a pill. But the VA, allowed by law to negotiate prices, brought down the price. The VA estimated that the drugs would cost roughly $750 million and provide about 60,000 treatments over 2017 and 2018, at about $25,300 per service member .

The VA then began treating close to 2,000 veterans with HCV every week—nearly 1 treatment started every minute of every workday. As a result, by the next year the overall death rate had dropped dramatically. Veterans cured of HCV were also 84% less likely to develop liver cancer.

 

 

Still, some patients have been left out. The OIG conducted a study to, among other things, assess why some patients with chronic HCV infection were not treated with DAAs. Acceptable reasons included pregnancy, being in hospice or palliative care, the possibility of drug interactions with current medications, a diagnosis of liver cancer, and adherence challenges (eg, being homeless). Unacceptable reasons included HIV co-infection and prior treatment failure with DAAs.

The decision to disqualify a patient from receiving HCV treatment must be made on a case-by-case basis by individual providers in consultation with their patients, the OIG says. If a patient is deferred for treatment based on “problematic levels of alcohol or substance use,” the report adds, he/she should be referred for substance use treatment and must have a plan for re-evaluation for HCV treatment within 3 to 6 months. However, the VHA notes that patients with drug or alcohol addiction “should not be automatically excluded from hepatitis C treatment.”

The VA says it is on track to treat more than 125,000 veterans with HCV by October. As of March, fewer than 27,000 remained to be treated.

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The VA is “within striking distance” of eliminating the hepatitis C virus in all veterans “willing and able to be treated,” with the expectation that everyone eligible will be cured by late this year.
The VA is “within striking distance” of eliminating the hepatitis C virus in all veterans “willing and able to be treated,” with the expectation that everyone eligible will be cured by late this year.

“This is terrific news,” said US Department of Veterans Affairs (VA) Secretary Robert Wilkie, noting that the VA is the largest single provider of hepatitis C virus (HCV) care in the US. “Diagnosing, treating, and curing hepatitis C virus infection among veterans has been a significant priority for VA.” According to the Review of Hepatitis C Virus Care within the Veterans Health Administration, published last month by the VA Office of Inspector General (OIG), the VA cares for more than 180,000 confirmed patients who are disproportionately affected by HCV infection, at rates about 3 times that of the national average.

As of March, nearly 116,000 veterans had started all-oral HCV medications. Almost 100,000 have completed treatment and are now cured. As an article in Forbes magazine pointed out, that is a story very different from the one reported just a few years earlier, when HCV treatment was out of reach for the tens of thousands of service members seriously ill with HCV, most of whom contracted it during blood transfusions in the Vietnam War.

The good news is due largely to the use of highly effective direct-acting antivirals (DAAs), which have revolutionized HCV treatment. Before 2014, HCV treatment required weekly interferon injections for up to a year, with low cure rates (35%-55%) and significant physical and psychiatric adverse effects (AEs), leading to frequent early discontinuation. Of the approximately 180,000 veterans in VA care at that time who had been diagnosed with chronic HCV infection, only 12,000 had been treated and cured. More than 30,000 had advanced liver disease.

In 2014, the VA launched an “aggressive program” to identify all undiagnosed veterans with HCV, link them to care, and offer them treatment with the new medications: sofosbuvir (Sovaldi) and simeprevir (Olysio). They have few AEs and can be administered once daily for as few as 8 weeks.

However, those drugs were incredibly expensive, prohibitively so for many people. Sovaldi cost $1,000 a pill. But the VA, allowed by law to negotiate prices, brought down the price. The VA estimated that the drugs would cost roughly $750 million and provide about 60,000 treatments over 2017 and 2018, at about $25,300 per service member .

The VA then began treating close to 2,000 veterans with HCV every week—nearly 1 treatment started every minute of every workday. As a result, by the next year the overall death rate had dropped dramatically. Veterans cured of HCV were also 84% less likely to develop liver cancer.

 

 

Still, some patients have been left out. The OIG conducted a study to, among other things, assess why some patients with chronic HCV infection were not treated with DAAs. Acceptable reasons included pregnancy, being in hospice or palliative care, the possibility of drug interactions with current medications, a diagnosis of liver cancer, and adherence challenges (eg, being homeless). Unacceptable reasons included HIV co-infection and prior treatment failure with DAAs.

The decision to disqualify a patient from receiving HCV treatment must be made on a case-by-case basis by individual providers in consultation with their patients, the OIG says. If a patient is deferred for treatment based on “problematic levels of alcohol or substance use,” the report adds, he/she should be referred for substance use treatment and must have a plan for re-evaluation for HCV treatment within 3 to 6 months. However, the VHA notes that patients with drug or alcohol addiction “should not be automatically excluded from hepatitis C treatment.”

The VA says it is on track to treat more than 125,000 veterans with HCV by October. As of March, fewer than 27,000 remained to be treated.

“This is terrific news,” said US Department of Veterans Affairs (VA) Secretary Robert Wilkie, noting that the VA is the largest single provider of hepatitis C virus (HCV) care in the US. “Diagnosing, treating, and curing hepatitis C virus infection among veterans has been a significant priority for VA.” According to the Review of Hepatitis C Virus Care within the Veterans Health Administration, published last month by the VA Office of Inspector General (OIG), the VA cares for more than 180,000 confirmed patients who are disproportionately affected by HCV infection, at rates about 3 times that of the national average.

As of March, nearly 116,000 veterans had started all-oral HCV medications. Almost 100,000 have completed treatment and are now cured. As an article in Forbes magazine pointed out, that is a story very different from the one reported just a few years earlier, when HCV treatment was out of reach for the tens of thousands of service members seriously ill with HCV, most of whom contracted it during blood transfusions in the Vietnam War.

The good news is due largely to the use of highly effective direct-acting antivirals (DAAs), which have revolutionized HCV treatment. Before 2014, HCV treatment required weekly interferon injections for up to a year, with low cure rates (35%-55%) and significant physical and psychiatric adverse effects (AEs), leading to frequent early discontinuation. Of the approximately 180,000 veterans in VA care at that time who had been diagnosed with chronic HCV infection, only 12,000 had been treated and cured. More than 30,000 had advanced liver disease.

In 2014, the VA launched an “aggressive program” to identify all undiagnosed veterans with HCV, link them to care, and offer them treatment with the new medications: sofosbuvir (Sovaldi) and simeprevir (Olysio). They have few AEs and can be administered once daily for as few as 8 weeks.

However, those drugs were incredibly expensive, prohibitively so for many people. Sovaldi cost $1,000 a pill. But the VA, allowed by law to negotiate prices, brought down the price. The VA estimated that the drugs would cost roughly $750 million and provide about 60,000 treatments over 2017 and 2018, at about $25,300 per service member .

The VA then began treating close to 2,000 veterans with HCV every week—nearly 1 treatment started every minute of every workday. As a result, by the next year the overall death rate had dropped dramatically. Veterans cured of HCV were also 84% less likely to develop liver cancer.

 

 

Still, some patients have been left out. The OIG conducted a study to, among other things, assess why some patients with chronic HCV infection were not treated with DAAs. Acceptable reasons included pregnancy, being in hospice or palliative care, the possibility of drug interactions with current medications, a diagnosis of liver cancer, and adherence challenges (eg, being homeless). Unacceptable reasons included HIV co-infection and prior treatment failure with DAAs.

The decision to disqualify a patient from receiving HCV treatment must be made on a case-by-case basis by individual providers in consultation with their patients, the OIG says. If a patient is deferred for treatment based on “problematic levels of alcohol or substance use,” the report adds, he/she should be referred for substance use treatment and must have a plan for re-evaluation for HCV treatment within 3 to 6 months. However, the VHA notes that patients with drug or alcohol addiction “should not be automatically excluded from hepatitis C treatment.”

The VA says it is on track to treat more than 125,000 veterans with HCV by October. As of March, fewer than 27,000 remained to be treated.

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Help for Guard and Reserve Members at Risk for Suicide

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In the ongoing discussion about the suicide rate among veterans, some people may have forgotten the former Guard and Reserve members who were never federally activated—yet also are at risk.

Every day in 2005, 18.5 service members and veterans committed suicide; of those, 2.7 were active-duty and non-activated Guard or Reserve. In 2015, those numbers had risen to 20.6 deaths per day, of which 3.8 were among active-duty or non-activated Guard and Reserve members. According to the VA’s most recent analysis, 7,298 current and former service members committed suicide in 2016. Of those, 902 were former Guard and Reserve members.

National Guard and Reserve members may not have veteran legal status due to their type of service, which can limit their access to VA benefits and services under current laws and regulations. In partnership with the DoD, VA now operates a mobile Vet Center to increase Guard and Reserve members’ access to mental health care.

To further help them, their families, and their health care providers, the VA also has developed a tool kit with links to mental health and suicide prevention resources that are available through the VA and their communities. “Extending support to former Guard and Reserve members at the community level is an important aspect of VA’s public health approach to preventing suicide,” said Dr. Keita Franklin, executive director for suicide prevention in the VA Office of Mental Health and Suicide Prevention.  

The resources include online suicide prevention training, mobile apps that help with managing daily stressors, and supportive services for family members who are seeking care for former service members.

InTransition, for instance, is a free confidential program that offers coaching and specialized assistance over the phone for service members who need access to mental health care. Military OneSource provides military personnel and their families with round-the-clock support for a wide range of civilian necessities, such as tax preparation and spouse employment. PsychArmor Institute provides free online education to anyone who works with, lives with, or cares for service members, veterans, and their families. The MY3-Support Network app allows users to add the contact information of 3 people they would like to talk to when they are having thoughts of suicide.

The tool kit also offers links to programs for community members who want to learn how to help prevent suicides and support families who have gone through the trauma. The #BeThere Campaign teaches how simple acts can help save the life of a veteran in crisis. The S.A.V.E. Training video, designed in collaboration with PsychArmor Institute, teaches how to demonstrate support and compassion when talking with a veteran who may be at risk. Other links lead users to ways to help those whose loved one has committed suicide, such as the Tragedy Assistance Program for Survivors (TAPS).

Further expansion of suicide prevention activities for the former Guard and Reserve population is planned for fiscal year 2019.

The Veterans Crisis Line is available with free confidential support and crisis intervention 24 hours a day, 7 days a week, 365 days a year: Call 800.273.8255 (press 1), text to 838255, or chat online at VeteransCrisisLine.net/Chat. The tool kit is available at https://www.mentalhealth.va.gov/suicide_prevention/docs/toolkit_National_Guard_and_Reserve_members_cleared_2-21-19.pdf.

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In the ongoing discussion about the suicide rate among veterans, some people may have forgotten the former Guard and Reserve members who were never federally activated—yet also are at risk.
In the ongoing discussion about the suicide rate among veterans, some people may have forgotten the former Guard and Reserve members who were never federally activated—yet also are at risk.

Every day in 2005, 18.5 service members and veterans committed suicide; of those, 2.7 were active-duty and non-activated Guard or Reserve. In 2015, those numbers had risen to 20.6 deaths per day, of which 3.8 were among active-duty or non-activated Guard and Reserve members. According to the VA’s most recent analysis, 7,298 current and former service members committed suicide in 2016. Of those, 902 were former Guard and Reserve members.

National Guard and Reserve members may not have veteran legal status due to their type of service, which can limit their access to VA benefits and services under current laws and regulations. In partnership with the DoD, VA now operates a mobile Vet Center to increase Guard and Reserve members’ access to mental health care.

To further help them, their families, and their health care providers, the VA also has developed a tool kit with links to mental health and suicide prevention resources that are available through the VA and their communities. “Extending support to former Guard and Reserve members at the community level is an important aspect of VA’s public health approach to preventing suicide,” said Dr. Keita Franklin, executive director for suicide prevention in the VA Office of Mental Health and Suicide Prevention.  

The resources include online suicide prevention training, mobile apps that help with managing daily stressors, and supportive services for family members who are seeking care for former service members.

InTransition, for instance, is a free confidential program that offers coaching and specialized assistance over the phone for service members who need access to mental health care. Military OneSource provides military personnel and their families with round-the-clock support for a wide range of civilian necessities, such as tax preparation and spouse employment. PsychArmor Institute provides free online education to anyone who works with, lives with, or cares for service members, veterans, and their families. The MY3-Support Network app allows users to add the contact information of 3 people they would like to talk to when they are having thoughts of suicide.

The tool kit also offers links to programs for community members who want to learn how to help prevent suicides and support families who have gone through the trauma. The #BeThere Campaign teaches how simple acts can help save the life of a veteran in crisis. The S.A.V.E. Training video, designed in collaboration with PsychArmor Institute, teaches how to demonstrate support and compassion when talking with a veteran who may be at risk. Other links lead users to ways to help those whose loved one has committed suicide, such as the Tragedy Assistance Program for Survivors (TAPS).

Further expansion of suicide prevention activities for the former Guard and Reserve population is planned for fiscal year 2019.

The Veterans Crisis Line is available with free confidential support and crisis intervention 24 hours a day, 7 days a week, 365 days a year: Call 800.273.8255 (press 1), text to 838255, or chat online at VeteransCrisisLine.net/Chat. The tool kit is available at https://www.mentalhealth.va.gov/suicide_prevention/docs/toolkit_National_Guard_and_Reserve_members_cleared_2-21-19.pdf.

Every day in 2005, 18.5 service members and veterans committed suicide; of those, 2.7 were active-duty and non-activated Guard or Reserve. In 2015, those numbers had risen to 20.6 deaths per day, of which 3.8 were among active-duty or non-activated Guard and Reserve members. According to the VA’s most recent analysis, 7,298 current and former service members committed suicide in 2016. Of those, 902 were former Guard and Reserve members.

National Guard and Reserve members may not have veteran legal status due to their type of service, which can limit their access to VA benefits and services under current laws and regulations. In partnership with the DoD, VA now operates a mobile Vet Center to increase Guard and Reserve members’ access to mental health care.

To further help them, their families, and their health care providers, the VA also has developed a tool kit with links to mental health and suicide prevention resources that are available through the VA and their communities. “Extending support to former Guard and Reserve members at the community level is an important aspect of VA’s public health approach to preventing suicide,” said Dr. Keita Franklin, executive director for suicide prevention in the VA Office of Mental Health and Suicide Prevention.  

The resources include online suicide prevention training, mobile apps that help with managing daily stressors, and supportive services for family members who are seeking care for former service members.

InTransition, for instance, is a free confidential program that offers coaching and specialized assistance over the phone for service members who need access to mental health care. Military OneSource provides military personnel and their families with round-the-clock support for a wide range of civilian necessities, such as tax preparation and spouse employment. PsychArmor Institute provides free online education to anyone who works with, lives with, or cares for service members, veterans, and their families. The MY3-Support Network app allows users to add the contact information of 3 people they would like to talk to when they are having thoughts of suicide.

The tool kit also offers links to programs for community members who want to learn how to help prevent suicides and support families who have gone through the trauma. The #BeThere Campaign teaches how simple acts can help save the life of a veteran in crisis. The S.A.V.E. Training video, designed in collaboration with PsychArmor Institute, teaches how to demonstrate support and compassion when talking with a veteran who may be at risk. Other links lead users to ways to help those whose loved one has committed suicide, such as the Tragedy Assistance Program for Survivors (TAPS).

Further expansion of suicide prevention activities for the former Guard and Reserve population is planned for fiscal year 2019.

The Veterans Crisis Line is available with free confidential support and crisis intervention 24 hours a day, 7 days a week, 365 days a year: Call 800.273.8255 (press 1), text to 838255, or chat online at VeteransCrisisLine.net/Chat. The tool kit is available at https://www.mentalhealth.va.gov/suicide_prevention/docs/toolkit_National_Guard_and_Reserve_members_cleared_2-21-19.pdf.

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Trial Opens to Study New Drug for Opioid Cravings

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Researchers are starting a new trial at the National Institutes of Health Clinical Center, hoping to find out how to curb the cravings that plague people with opioid dependence.

Habitual use of opioids “rewires” the brain’s reward system. In the study, researchers will be testing ANS-6637 (Amygdala Neurosciences), a drug that may inhibit the dopamine surge of opioid use, without affecting the levels of dopamine needed for normal brain function.

The phase 1 trial will enroll up to 50 healthy adults aged 18 to 65 years. On the first day of the 10-day study, they will receive a single dose of midazolam, chosen to act as a template for liver metabolism. After a drug-free day 2, on days 3 through 7 they will receive 600 mg/d of ANS-6637. On day 8, the participants will be given the 2 drugs together to determine how the investigational drug affects midazolam levels, which also will help the researchers understand how ANS-6637 is processed in the body. The volunteers will return for a final outpatient visit after 1 week.

At present, few pharmacologic interventions target opioid-related cravings, says researcher Henry Masur, MD, chief of the Clinical Center’s Critical Care Medicine Department. If proven effective, the researchers say, ANS-6637 could be part of a comprehensive package of services, including harm reduction, opioid agonist therapy, and behavioral interventions.

The study is funded through NIH’s Helping to End Addiction Long-Term (HEAL) Initiative, an “aggressive, trans-agency effort to speed scientific solutions” to the opioid crisis.

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Researchers are starting a new trial at the National Institutes of Health Clinical Center, hoping to find out how to curb the cravings that plague people with opioid dependence.
Researchers are starting a new trial at the National Institutes of Health Clinical Center, hoping to find out how to curb the cravings that plague people with opioid dependence.

Habitual use of opioids “rewires” the brain’s reward system. In the study, researchers will be testing ANS-6637 (Amygdala Neurosciences), a drug that may inhibit the dopamine surge of opioid use, without affecting the levels of dopamine needed for normal brain function.

The phase 1 trial will enroll up to 50 healthy adults aged 18 to 65 years. On the first day of the 10-day study, they will receive a single dose of midazolam, chosen to act as a template for liver metabolism. After a drug-free day 2, on days 3 through 7 they will receive 600 mg/d of ANS-6637. On day 8, the participants will be given the 2 drugs together to determine how the investigational drug affects midazolam levels, which also will help the researchers understand how ANS-6637 is processed in the body. The volunteers will return for a final outpatient visit after 1 week.

At present, few pharmacologic interventions target opioid-related cravings, says researcher Henry Masur, MD, chief of the Clinical Center’s Critical Care Medicine Department. If proven effective, the researchers say, ANS-6637 could be part of a comprehensive package of services, including harm reduction, opioid agonist therapy, and behavioral interventions.

The study is funded through NIH’s Helping to End Addiction Long-Term (HEAL) Initiative, an “aggressive, trans-agency effort to speed scientific solutions” to the opioid crisis.

Habitual use of opioids “rewires” the brain’s reward system. In the study, researchers will be testing ANS-6637 (Amygdala Neurosciences), a drug that may inhibit the dopamine surge of opioid use, without affecting the levels of dopamine needed for normal brain function.

The phase 1 trial will enroll up to 50 healthy adults aged 18 to 65 years. On the first day of the 10-day study, they will receive a single dose of midazolam, chosen to act as a template for liver metabolism. After a drug-free day 2, on days 3 through 7 they will receive 600 mg/d of ANS-6637. On day 8, the participants will be given the 2 drugs together to determine how the investigational drug affects midazolam levels, which also will help the researchers understand how ANS-6637 is processed in the body. The volunteers will return for a final outpatient visit after 1 week.

At present, few pharmacologic interventions target opioid-related cravings, says researcher Henry Masur, MD, chief of the Clinical Center’s Critical Care Medicine Department. If proven effective, the researchers say, ANS-6637 could be part of a comprehensive package of services, including harm reduction, opioid agonist therapy, and behavioral interventions.

The study is funded through NIH’s Helping to End Addiction Long-Term (HEAL) Initiative, an “aggressive, trans-agency effort to speed scientific solutions” to the opioid crisis.

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Making HIV Transmission a Rare Event

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Although researchers have found a lack of effective treatment and diagnosis in many patients with HIV, they find how to greatly reduce virus transmission.

About 80% of new HIV transmissions are from people who do not know they have HIV or are not receiving regular care, according to a CDC report. That makes improvements in early detection and “rapid entry into care” key to ending the HIV epidemic within 10 years—the current US Department of Health and Human Services goal.

Recent studies have shown that viral suppression prevents sexual transmission of HIV, the researchers say. The studies found no HIV transmissions attributable to sex between HIV-discordant couples when the HIV-infected partner was maintaining viral suppression through treatment—even when the HIV-negative partner was not using preexposure prophylaxis. Those findings mean HIV transmission can become a “rare event,” the researchers say.

Today’s treatments have gotten simpler than the hills of pills that patients used to take. Sometimes the patient needs only a single-tablet regimen. Most people, according to the CDC, can achieve viral suppression within 6 months of starting treatment.

But many of the 1.1 million people with HIV infection are not effectively treated. In 2015, the CDC researchers say, 14.5% of people with HIV infection did not have a diagnosis, and 37.2% were not in care (receiving ≥ 1 CD4 tests in a measurement year). Nearly half were not virally suppressed. Lack of effective treatment results in worse outcomes and higher rates of transmission: It was associated with 38,700 new HIV infections in 2016.

The researchers used a model to estimate transmission rates in 2016 along the HIV continuum of care. Overall, the rate was 3.5 per 100 person-years. Among 9,600 people who were acutely infected and unaware of their infection, the rate was 16.1 per 100 person-years. Among 154,400 people who were nonacutely infected and unaware, the rate was 8.4.

Of the nearly 250,000 people who were aware of HIV infection but not in care, 16,500 transmissions were generated (6.6/100 person-years). Among the 125,300 who were receiving HIV care but not virally suppressed, 7,700 transmissions were generated (6.1).

The transmission rate was 0 for patients who were virally suppressed. The researchers note that 100% efficacy was assumed based on trial results for sexual transmission; no data are available on the efficacy of viral suppression on reducing HIV transmission from IV drug use.

Better detection and linkage to treatment will address most of the problem, but what about the patients who do not maintain viral suppression? Among patients in clinical care, about 80% were virally suppressed at their most recent visit, but about one-third did not sustain viral suppression over 1 year. For those patients, the researchers say, a tailored approach aimed at the barriers that are most relevant for the patient is critical to improving adherence.

The CDC recommends routine screening of all Americans aged 13 to 64 years at least once in their life and at least annual testing for those at high risk. In addition, the researchers say, it is important to spread the word that maintaining viral suppression prevents sexual transmission. Sharing this knowledge more generally might reduce the stigma associated with HIV and help engage patients in consistent care.

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Although researchers have found a lack of effective treatment and diagnosis in many patients with HIV, they find how to greatly reduce virus transmission.
Although researchers have found a lack of effective treatment and diagnosis in many patients with HIV, they find how to greatly reduce virus transmission.

About 80% of new HIV transmissions are from people who do not know they have HIV or are not receiving regular care, according to a CDC report. That makes improvements in early detection and “rapid entry into care” key to ending the HIV epidemic within 10 years—the current US Department of Health and Human Services goal.

Recent studies have shown that viral suppression prevents sexual transmission of HIV, the researchers say. The studies found no HIV transmissions attributable to sex between HIV-discordant couples when the HIV-infected partner was maintaining viral suppression through treatment—even when the HIV-negative partner was not using preexposure prophylaxis. Those findings mean HIV transmission can become a “rare event,” the researchers say.

Today’s treatments have gotten simpler than the hills of pills that patients used to take. Sometimes the patient needs only a single-tablet regimen. Most people, according to the CDC, can achieve viral suppression within 6 months of starting treatment.

But many of the 1.1 million people with HIV infection are not effectively treated. In 2015, the CDC researchers say, 14.5% of people with HIV infection did not have a diagnosis, and 37.2% were not in care (receiving ≥ 1 CD4 tests in a measurement year). Nearly half were not virally suppressed. Lack of effective treatment results in worse outcomes and higher rates of transmission: It was associated with 38,700 new HIV infections in 2016.

The researchers used a model to estimate transmission rates in 2016 along the HIV continuum of care. Overall, the rate was 3.5 per 100 person-years. Among 9,600 people who were acutely infected and unaware of their infection, the rate was 16.1 per 100 person-years. Among 154,400 people who were nonacutely infected and unaware, the rate was 8.4.

Of the nearly 250,000 people who were aware of HIV infection but not in care, 16,500 transmissions were generated (6.6/100 person-years). Among the 125,300 who were receiving HIV care but not virally suppressed, 7,700 transmissions were generated (6.1).

The transmission rate was 0 for patients who were virally suppressed. The researchers note that 100% efficacy was assumed based on trial results for sexual transmission; no data are available on the efficacy of viral suppression on reducing HIV transmission from IV drug use.

Better detection and linkage to treatment will address most of the problem, but what about the patients who do not maintain viral suppression? Among patients in clinical care, about 80% were virally suppressed at their most recent visit, but about one-third did not sustain viral suppression over 1 year. For those patients, the researchers say, a tailored approach aimed at the barriers that are most relevant for the patient is critical to improving adherence.

The CDC recommends routine screening of all Americans aged 13 to 64 years at least once in their life and at least annual testing for those at high risk. In addition, the researchers say, it is important to spread the word that maintaining viral suppression prevents sexual transmission. Sharing this knowledge more generally might reduce the stigma associated with HIV and help engage patients in consistent care.

About 80% of new HIV transmissions are from people who do not know they have HIV or are not receiving regular care, according to a CDC report. That makes improvements in early detection and “rapid entry into care” key to ending the HIV epidemic within 10 years—the current US Department of Health and Human Services goal.

Recent studies have shown that viral suppression prevents sexual transmission of HIV, the researchers say. The studies found no HIV transmissions attributable to sex between HIV-discordant couples when the HIV-infected partner was maintaining viral suppression through treatment—even when the HIV-negative partner was not using preexposure prophylaxis. Those findings mean HIV transmission can become a “rare event,” the researchers say.

Today’s treatments have gotten simpler than the hills of pills that patients used to take. Sometimes the patient needs only a single-tablet regimen. Most people, according to the CDC, can achieve viral suppression within 6 months of starting treatment.

But many of the 1.1 million people with HIV infection are not effectively treated. In 2015, the CDC researchers say, 14.5% of people with HIV infection did not have a diagnosis, and 37.2% were not in care (receiving ≥ 1 CD4 tests in a measurement year). Nearly half were not virally suppressed. Lack of effective treatment results in worse outcomes and higher rates of transmission: It was associated with 38,700 new HIV infections in 2016.

The researchers used a model to estimate transmission rates in 2016 along the HIV continuum of care. Overall, the rate was 3.5 per 100 person-years. Among 9,600 people who were acutely infected and unaware of their infection, the rate was 16.1 per 100 person-years. Among 154,400 people who were nonacutely infected and unaware, the rate was 8.4.

Of the nearly 250,000 people who were aware of HIV infection but not in care, 16,500 transmissions were generated (6.6/100 person-years). Among the 125,300 who were receiving HIV care but not virally suppressed, 7,700 transmissions were generated (6.1).

The transmission rate was 0 for patients who were virally suppressed. The researchers note that 100% efficacy was assumed based on trial results for sexual transmission; no data are available on the efficacy of viral suppression on reducing HIV transmission from IV drug use.

Better detection and linkage to treatment will address most of the problem, but what about the patients who do not maintain viral suppression? Among patients in clinical care, about 80% were virally suppressed at their most recent visit, but about one-third did not sustain viral suppression over 1 year. For those patients, the researchers say, a tailored approach aimed at the barriers that are most relevant for the patient is critical to improving adherence.

The CDC recommends routine screening of all Americans aged 13 to 64 years at least once in their life and at least annual testing for those at high risk. In addition, the researchers say, it is important to spread the word that maintaining viral suppression prevents sexual transmission. Sharing this knowledge more generally might reduce the stigma associated with HIV and help engage patients in consistent care.

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Do Collaborative Models Work for Mental Health in a General Clinical Setting?

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To reduce the amount of mental health hospitalization, researchers analyze the effects of using collaborative chronic care models to treat patients within the VA health care system in a general clinical setting.

Collaborative chronic care models (CCMs) are effective in serious mental illnesses, which has been shown in extensive randomized clinical trials. Much of their effectiveness comes from the emphasis on flexibility: They are implemented according to local needs, capabilities, and priorities. Collaborative chronic care models also provide support: for redesigned work roles that promote “anticipatory” continuous care, for self-management, and for clinical decision making at a local level.

In 2013, the VA Office of Mental Health and Suicide Prevention (OMHSP) began an initiative to enhance care coordination in general mental health clinics with mixed-diagnosis populations. It established interdisciplinary teams in each VA medical center throughout the US. Although providing centrally developed guidance, VAOMHSP gave facilities “broad latitude” to develop their team processes. In 2015, VAOMHSP adopted the CCM.

But most of the data on how well CCMs work for mental health conditions come from depression treatment in primary care—and the effects seem to be inconsistent. So researchers from Veterans Affairs Boston Healthcare System and others partnered with VAOMHSP to find out whether the CCM model would be effective in a general clinical setting.

They recruited 9 VA facilities for a 2-year study conducted in 3 waves. The implementation strategy was based on the premise that “health care is a complex adaptive system rather than a highly controlled machine.” That is, it would work best if local solutions for local challenges could be developed in accordance with evidence-based guidance. The multifaceted approach included an external facilitator who provided guidance and quality improvement expertise and an on-site internal facilitator to direct the implementation.

In the study, 5,596 veterans treated by outpatient general mental health teams were included in hospitalization analyses. A randomly selected sample of 1,050 (including 210 women) was identified for health status interviews.

The researchers found a “robust” and sustained reduction in mental health hospitalization. However, the effects on self-reported health outcomes were “limited,” the researchers say. The mental component score (the primary intervention outcome) did not change statistically significantly with implementation support in adjusted or unadjusted models, nor did other interview measures. The researchers say they saw no difference in the way veterans were treated between higher and lower implementing teams.

In post hoc analyses, though, patients with more complex problems, defined as receiving treatment for ≥ 3 mental health diagnoses in the previous year, did show statistically significant improvements in the facilitation year (by a magnitude of 0.31 SD). By contrast, those with ≤ 2 diagnoses declined nonsignificantly during the same time. The researchers note that other studies have found that CCM-based teams in patient-centered medical homes have also shown more benefit among higher morbidity patients.

Overall, the model was shown to be effectively implemented with “practical, scalable support” for clinicians. Another benefit was that teams performed better, the researchers found. They assessed team function at baseline and during the second 6 months on measures, including communication, cohesion, role clarity, and team primacy (prioritizing team over individual goals). The subscales showed high ratings for cohesion and communication at baseline, which did not change with implementation support. However, role clarity and team primacy improved significantly. The researchers conclude that under typical practice conditions CCMs can help the clinicians help the sickest patients.

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To reduce the amount of mental health hospitalization, researchers analyze the effects of using collaborative chronic care models to treat patients within the VA health care system in a general clinical setting.
To reduce the amount of mental health hospitalization, researchers analyze the effects of using collaborative chronic care models to treat patients within the VA health care system in a general clinical setting.

Collaborative chronic care models (CCMs) are effective in serious mental illnesses, which has been shown in extensive randomized clinical trials. Much of their effectiveness comes from the emphasis on flexibility: They are implemented according to local needs, capabilities, and priorities. Collaborative chronic care models also provide support: for redesigned work roles that promote “anticipatory” continuous care, for self-management, and for clinical decision making at a local level.

In 2013, the VA Office of Mental Health and Suicide Prevention (OMHSP) began an initiative to enhance care coordination in general mental health clinics with mixed-diagnosis populations. It established interdisciplinary teams in each VA medical center throughout the US. Although providing centrally developed guidance, VAOMHSP gave facilities “broad latitude” to develop their team processes. In 2015, VAOMHSP adopted the CCM.

But most of the data on how well CCMs work for mental health conditions come from depression treatment in primary care—and the effects seem to be inconsistent. So researchers from Veterans Affairs Boston Healthcare System and others partnered with VAOMHSP to find out whether the CCM model would be effective in a general clinical setting.

They recruited 9 VA facilities for a 2-year study conducted in 3 waves. The implementation strategy was based on the premise that “health care is a complex adaptive system rather than a highly controlled machine.” That is, it would work best if local solutions for local challenges could be developed in accordance with evidence-based guidance. The multifaceted approach included an external facilitator who provided guidance and quality improvement expertise and an on-site internal facilitator to direct the implementation.

In the study, 5,596 veterans treated by outpatient general mental health teams were included in hospitalization analyses. A randomly selected sample of 1,050 (including 210 women) was identified for health status interviews.

The researchers found a “robust” and sustained reduction in mental health hospitalization. However, the effects on self-reported health outcomes were “limited,” the researchers say. The mental component score (the primary intervention outcome) did not change statistically significantly with implementation support in adjusted or unadjusted models, nor did other interview measures. The researchers say they saw no difference in the way veterans were treated between higher and lower implementing teams.

In post hoc analyses, though, patients with more complex problems, defined as receiving treatment for ≥ 3 mental health diagnoses in the previous year, did show statistically significant improvements in the facilitation year (by a magnitude of 0.31 SD). By contrast, those with ≤ 2 diagnoses declined nonsignificantly during the same time. The researchers note that other studies have found that CCM-based teams in patient-centered medical homes have also shown more benefit among higher morbidity patients.

Overall, the model was shown to be effectively implemented with “practical, scalable support” for clinicians. Another benefit was that teams performed better, the researchers found. They assessed team function at baseline and during the second 6 months on measures, including communication, cohesion, role clarity, and team primacy (prioritizing team over individual goals). The subscales showed high ratings for cohesion and communication at baseline, which did not change with implementation support. However, role clarity and team primacy improved significantly. The researchers conclude that under typical practice conditions CCMs can help the clinicians help the sickest patients.

Collaborative chronic care models (CCMs) are effective in serious mental illnesses, which has been shown in extensive randomized clinical trials. Much of their effectiveness comes from the emphasis on flexibility: They are implemented according to local needs, capabilities, and priorities. Collaborative chronic care models also provide support: for redesigned work roles that promote “anticipatory” continuous care, for self-management, and for clinical decision making at a local level.

In 2013, the VA Office of Mental Health and Suicide Prevention (OMHSP) began an initiative to enhance care coordination in general mental health clinics with mixed-diagnosis populations. It established interdisciplinary teams in each VA medical center throughout the US. Although providing centrally developed guidance, VAOMHSP gave facilities “broad latitude” to develop their team processes. In 2015, VAOMHSP adopted the CCM.

But most of the data on how well CCMs work for mental health conditions come from depression treatment in primary care—and the effects seem to be inconsistent. So researchers from Veterans Affairs Boston Healthcare System and others partnered with VAOMHSP to find out whether the CCM model would be effective in a general clinical setting.

They recruited 9 VA facilities for a 2-year study conducted in 3 waves. The implementation strategy was based on the premise that “health care is a complex adaptive system rather than a highly controlled machine.” That is, it would work best if local solutions for local challenges could be developed in accordance with evidence-based guidance. The multifaceted approach included an external facilitator who provided guidance and quality improvement expertise and an on-site internal facilitator to direct the implementation.

In the study, 5,596 veterans treated by outpatient general mental health teams were included in hospitalization analyses. A randomly selected sample of 1,050 (including 210 women) was identified for health status interviews.

The researchers found a “robust” and sustained reduction in mental health hospitalization. However, the effects on self-reported health outcomes were “limited,” the researchers say. The mental component score (the primary intervention outcome) did not change statistically significantly with implementation support in adjusted or unadjusted models, nor did other interview measures. The researchers say they saw no difference in the way veterans were treated between higher and lower implementing teams.

In post hoc analyses, though, patients with more complex problems, defined as receiving treatment for ≥ 3 mental health diagnoses in the previous year, did show statistically significant improvements in the facilitation year (by a magnitude of 0.31 SD). By contrast, those with ≤ 2 diagnoses declined nonsignificantly during the same time. The researchers note that other studies have found that CCM-based teams in patient-centered medical homes have also shown more benefit among higher morbidity patients.

Overall, the model was shown to be effectively implemented with “practical, scalable support” for clinicians. Another benefit was that teams performed better, the researchers found. They assessed team function at baseline and during the second 6 months on measures, including communication, cohesion, role clarity, and team primacy (prioritizing team over individual goals). The subscales showed high ratings for cohesion and communication at baseline, which did not change with implementation support. However, role clarity and team primacy improved significantly. The researchers conclude that under typical practice conditions CCMs can help the clinicians help the sickest patients.

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VA Community Living Centers Health Care Reports Are Now Public

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Report results for 134 VA community living centers highlight the recent quality of care and outperformance of the private sector.

Although VA nursing homes, on the whole, have sicker patients than do those in private sector nursing homes, they compare closely in terms of quality of care—and in some cases, VA health care gets higher marks. VA has more higher performing facilities (17% vs 11%) and fewer low-performing facilities (17% vs 20%).

Those figures come from the health care inspection reports and staffing data for its 134 community living centers (CLCs) that the VA is, for the first time, posting publicly. So far, VA has posted 101 health inspection reports; the remainder are scheduled for later this year. The reports cover April 2018 to the present.

The VA reports are based on yearly, unannounced inspections conducted by an outside contracted agency. The survey teams assess a variety of aspects of life at VA nursing homes, such as the care of residents and the processes used to give that care, how the staff and residents interact, and the nursing home environment. The surveyors also review residents’ clinical records and interview residents, family members, caregivers, and staff.

VA nursing homes also had a significantly lower percentage (6%) of 1-star (lowest rated) nursing homes compared with 15,487 private sector nursing homes rated by the Centers for Medicare and Medicaid Services. Both Medicare-certified skilled nursing facilities and VA CLCs must meet federal standards, such as having enough staff to provide adequate care. “There is significant evidence of a relationship between resident outcomes and staffing levels in nursing homes,” the VA says in its description of survey criteria.

Many VA nursing home residents are being treated for conditions rarely seen in private sector nursing homes, the VA says, including veteran-specific conditions, such as posttraumatic stress disorder (12% vs 0.5%) and traumatic brain injury (2% vs 0.8%). In 2018, 42% of 41,076 VA CLC residents had a service-connected disability rating of ≥ 50%. CLCs also provide more hospice care and care for conditions related to homelessness.

However, the VA notes that “quality measures are not the same as quality standards.” According to Medicare Nursing Home Compare, the quality of resident care measures are not benchmarks, thresholds, guidelines, or standards of care—they are a “snapshot at a point in time” of the average condition of residents. For instance, individual CLCs may serve special populations and have a higher rate of certain conditions. A CLC that specializes in complex skin and wound care may admit veterans with severe pressure ulcers that occurred at home or another hospital.

Detailed information on individual quality measures and how VA facilities compare with others in their areas are available at www.accesstocare.va.gov/healthcare/qualityofcare. That site also has an interactive searchable map that can be used to locate CLCs by zip code or distance. The health inspection reports are available at www.va.gov/qualityofcare/apps/aspire/clcsurvey.aspx.

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Report results for 134 VA community living centers highlight the recent quality of care and outperformance of the private sector.
Report results for 134 VA community living centers highlight the recent quality of care and outperformance of the private sector.

Although VA nursing homes, on the whole, have sicker patients than do those in private sector nursing homes, they compare closely in terms of quality of care—and in some cases, VA health care gets higher marks. VA has more higher performing facilities (17% vs 11%) and fewer low-performing facilities (17% vs 20%).

Those figures come from the health care inspection reports and staffing data for its 134 community living centers (CLCs) that the VA is, for the first time, posting publicly. So far, VA has posted 101 health inspection reports; the remainder are scheduled for later this year. The reports cover April 2018 to the present.

The VA reports are based on yearly, unannounced inspections conducted by an outside contracted agency. The survey teams assess a variety of aspects of life at VA nursing homes, such as the care of residents and the processes used to give that care, how the staff and residents interact, and the nursing home environment. The surveyors also review residents’ clinical records and interview residents, family members, caregivers, and staff.

VA nursing homes also had a significantly lower percentage (6%) of 1-star (lowest rated) nursing homes compared with 15,487 private sector nursing homes rated by the Centers for Medicare and Medicaid Services. Both Medicare-certified skilled nursing facilities and VA CLCs must meet federal standards, such as having enough staff to provide adequate care. “There is significant evidence of a relationship between resident outcomes and staffing levels in nursing homes,” the VA says in its description of survey criteria.

Many VA nursing home residents are being treated for conditions rarely seen in private sector nursing homes, the VA says, including veteran-specific conditions, such as posttraumatic stress disorder (12% vs 0.5%) and traumatic brain injury (2% vs 0.8%). In 2018, 42% of 41,076 VA CLC residents had a service-connected disability rating of ≥ 50%. CLCs also provide more hospice care and care for conditions related to homelessness.

However, the VA notes that “quality measures are not the same as quality standards.” According to Medicare Nursing Home Compare, the quality of resident care measures are not benchmarks, thresholds, guidelines, or standards of care—they are a “snapshot at a point in time” of the average condition of residents. For instance, individual CLCs may serve special populations and have a higher rate of certain conditions. A CLC that specializes in complex skin and wound care may admit veterans with severe pressure ulcers that occurred at home or another hospital.

Detailed information on individual quality measures and how VA facilities compare with others in their areas are available at www.accesstocare.va.gov/healthcare/qualityofcare. That site also has an interactive searchable map that can be used to locate CLCs by zip code or distance. The health inspection reports are available at www.va.gov/qualityofcare/apps/aspire/clcsurvey.aspx.

Although VA nursing homes, on the whole, have sicker patients than do those in private sector nursing homes, they compare closely in terms of quality of care—and in some cases, VA health care gets higher marks. VA has more higher performing facilities (17% vs 11%) and fewer low-performing facilities (17% vs 20%).

Those figures come from the health care inspection reports and staffing data for its 134 community living centers (CLCs) that the VA is, for the first time, posting publicly. So far, VA has posted 101 health inspection reports; the remainder are scheduled for later this year. The reports cover April 2018 to the present.

The VA reports are based on yearly, unannounced inspections conducted by an outside contracted agency. The survey teams assess a variety of aspects of life at VA nursing homes, such as the care of residents and the processes used to give that care, how the staff and residents interact, and the nursing home environment. The surveyors also review residents’ clinical records and interview residents, family members, caregivers, and staff.

VA nursing homes also had a significantly lower percentage (6%) of 1-star (lowest rated) nursing homes compared with 15,487 private sector nursing homes rated by the Centers for Medicare and Medicaid Services. Both Medicare-certified skilled nursing facilities and VA CLCs must meet federal standards, such as having enough staff to provide adequate care. “There is significant evidence of a relationship between resident outcomes and staffing levels in nursing homes,” the VA says in its description of survey criteria.

Many VA nursing home residents are being treated for conditions rarely seen in private sector nursing homes, the VA says, including veteran-specific conditions, such as posttraumatic stress disorder (12% vs 0.5%) and traumatic brain injury (2% vs 0.8%). In 2018, 42% of 41,076 VA CLC residents had a service-connected disability rating of ≥ 50%. CLCs also provide more hospice care and care for conditions related to homelessness.

However, the VA notes that “quality measures are not the same as quality standards.” According to Medicare Nursing Home Compare, the quality of resident care measures are not benchmarks, thresholds, guidelines, or standards of care—they are a “snapshot at a point in time” of the average condition of residents. For instance, individual CLCs may serve special populations and have a higher rate of certain conditions. A CLC that specializes in complex skin and wound care may admit veterans with severe pressure ulcers that occurred at home or another hospital.

Detailed information on individual quality measures and how VA facilities compare with others in their areas are available at www.accesstocare.va.gov/healthcare/qualityofcare. That site also has an interactive searchable map that can be used to locate CLCs by zip code or distance. The health inspection reports are available at www.va.gov/qualityofcare/apps/aspire/clcsurvey.aspx.

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Universal “Test-and-Treat” Strategy Cuts Down New HIV Infections

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Mon, 03/25/2019 - 03:27
The largest HIV prevention study conducted to date found house-to-house HIV testing and providing immediate treatment referrals for everyone testing positive markedly reduced new HIV infections.

The findings suggest that a universal “test-and-treat” strategy could be “an important addition to our toolbox of proven HIV prevention modalities,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

The National Institute of Allergy and Infectious Diseases (NIAID)-sponsored study, Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART), was conducted from 2013 to 2018 in 21 urban and peri-urban communities in Zambia and South Africa, each with about 50,000 residents.

The communities were grouped as 7 “triplets” matched by geographic location and estimated HIV prevalence. The first group received annual house-to-house voluntary HIV testing and counseling, linkage to care for those testing positive, and the offer of a suite of proven prevention measures for those who tested negative. The second group received the same services as the first except treatment was offered according to national guidelines. The third group served as a control and received HIV prevention and testing services according to the local standard of care and HIV treatment according to national guidelines.

At the start of the study, the national guidelines for HIV treatment in Zambia and South Africa specified starting ART when the CD4+ T-cell count had declined to 350 cells/µL. In 2014, that threshold was raised to 500 cells/µL. In 2016, both countries recommended that everyone diagnosed with HIV begin ART immediately regardless of CD4+ T-cell count. Consequently, the first and second groups received the same intervention during the last 2 years of the study.

The researchers also recruited a random sample of about 2,300 adults from each community and visited them once a year for 3 years to collect data and test blood.

In the first 3 years, during nearly 40,000 person-years of follow-up, 553 people developed HIV infection (1.4 infections per 100 person-years). HIV incidence was 7% lower in group 1 than in the control group, although the difference was not statistically significant. However, HIV incidence was 30% lower in group 2 compared with that in the control group—a highly statistically significant and consistent result. (The researchers can’t explain why new HIV infections didn’t decline in all the communities where people who tested positive were offered immediate treatment.)

Of participants who tested positive by year 2, 72% of group 1, 68% of group 2, and 60% of the control group had achieved viral suppression.

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The largest HIV prevention study conducted to date found house-to-house HIV testing and providing immediate treatment referrals for everyone testing positive markedly reduced new HIV infections.
The largest HIV prevention study conducted to date found house-to-house HIV testing and providing immediate treatment referrals for everyone testing positive markedly reduced new HIV infections.

The findings suggest that a universal “test-and-treat” strategy could be “an important addition to our toolbox of proven HIV prevention modalities,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

The National Institute of Allergy and Infectious Diseases (NIAID)-sponsored study, Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART), was conducted from 2013 to 2018 in 21 urban and peri-urban communities in Zambia and South Africa, each with about 50,000 residents.

The communities were grouped as 7 “triplets” matched by geographic location and estimated HIV prevalence. The first group received annual house-to-house voluntary HIV testing and counseling, linkage to care for those testing positive, and the offer of a suite of proven prevention measures for those who tested negative. The second group received the same services as the first except treatment was offered according to national guidelines. The third group served as a control and received HIV prevention and testing services according to the local standard of care and HIV treatment according to national guidelines.

At the start of the study, the national guidelines for HIV treatment in Zambia and South Africa specified starting ART when the CD4+ T-cell count had declined to 350 cells/µL. In 2014, that threshold was raised to 500 cells/µL. In 2016, both countries recommended that everyone diagnosed with HIV begin ART immediately regardless of CD4+ T-cell count. Consequently, the first and second groups received the same intervention during the last 2 years of the study.

The researchers also recruited a random sample of about 2,300 adults from each community and visited them once a year for 3 years to collect data and test blood.

In the first 3 years, during nearly 40,000 person-years of follow-up, 553 people developed HIV infection (1.4 infections per 100 person-years). HIV incidence was 7% lower in group 1 than in the control group, although the difference was not statistically significant. However, HIV incidence was 30% lower in group 2 compared with that in the control group—a highly statistically significant and consistent result. (The researchers can’t explain why new HIV infections didn’t decline in all the communities where people who tested positive were offered immediate treatment.)

Of participants who tested positive by year 2, 72% of group 1, 68% of group 2, and 60% of the control group had achieved viral suppression.

The findings suggest that a universal “test-and-treat” strategy could be “an important addition to our toolbox of proven HIV prevention modalities,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

The National Institute of Allergy and Infectious Diseases (NIAID)-sponsored study, Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART), was conducted from 2013 to 2018 in 21 urban and peri-urban communities in Zambia and South Africa, each with about 50,000 residents.

The communities were grouped as 7 “triplets” matched by geographic location and estimated HIV prevalence. The first group received annual house-to-house voluntary HIV testing and counseling, linkage to care for those testing positive, and the offer of a suite of proven prevention measures for those who tested negative. The second group received the same services as the first except treatment was offered according to national guidelines. The third group served as a control and received HIV prevention and testing services according to the local standard of care and HIV treatment according to national guidelines.

At the start of the study, the national guidelines for HIV treatment in Zambia and South Africa specified starting ART when the CD4+ T-cell count had declined to 350 cells/µL. In 2014, that threshold was raised to 500 cells/µL. In 2016, both countries recommended that everyone diagnosed with HIV begin ART immediately regardless of CD4+ T-cell count. Consequently, the first and second groups received the same intervention during the last 2 years of the study.

The researchers also recruited a random sample of about 2,300 adults from each community and visited them once a year for 3 years to collect data and test blood.

In the first 3 years, during nearly 40,000 person-years of follow-up, 553 people developed HIV infection (1.4 infections per 100 person-years). HIV incidence was 7% lower in group 1 than in the control group, although the difference was not statistically significant. However, HIV incidence was 30% lower in group 2 compared with that in the control group—a highly statistically significant and consistent result. (The researchers can’t explain why new HIV infections didn’t decline in all the communities where people who tested positive were offered immediate treatment.)

Of participants who tested positive by year 2, 72% of group 1, 68% of group 2, and 60% of the control group had achieved viral suppression.

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Promising New Approach for Treating Cystic Fibrosis

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Fri, 03/22/2019 - 03:37
A longtime antifungal standard, amphotericin, may hold the key to reducing or even preventing the chronic infections that affect patients with cystic fibrosis.

In cystic fibrosis (CF), a defective gene makes a defective protein that causes acidic and sticky mucus that clogs the lungs and puts patients at risk for bacterial infections. Because different people have different protein mutations, and 10% of patients with CF make no protein at all, treatments are limited. But amphotericin apparently has the potential to work regardless of the mutation and even when the protein is missing. The researchers liken it to a “molecular prosthetic,” because it restores function much as a prosthetic device replaces a limb.

In the study, supported in part by the National Heart, Lung, and Blood Institute, researchers used lung tissue from patients with CF as well as animal models. Instead of trying to correct the protein or do gene therapy, which the researchers say is not yet effective in the lung, they used a small molecule protein that can perform the channel function of the missing or defective protein.

They found that amphotericin restored pH levels, improved viscosity, and increased antibacterial activity.

Amphotericin also can be delivered directly to the lungs to avoid common adverse effects, the researchers say. Although more studies are needed, according to the National Institute of Health, “experts are hopeful.”

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A longtime antifungal standard, amphotericin, may hold the key to reducing or even preventing the chronic infections that affect patients with cystic fibrosis.
A longtime antifungal standard, amphotericin, may hold the key to reducing or even preventing the chronic infections that affect patients with cystic fibrosis.

In cystic fibrosis (CF), a defective gene makes a defective protein that causes acidic and sticky mucus that clogs the lungs and puts patients at risk for bacterial infections. Because different people have different protein mutations, and 10% of patients with CF make no protein at all, treatments are limited. But amphotericin apparently has the potential to work regardless of the mutation and even when the protein is missing. The researchers liken it to a “molecular prosthetic,” because it restores function much as a prosthetic device replaces a limb.

In the study, supported in part by the National Heart, Lung, and Blood Institute, researchers used lung tissue from patients with CF as well as animal models. Instead of trying to correct the protein or do gene therapy, which the researchers say is not yet effective in the lung, they used a small molecule protein that can perform the channel function of the missing or defective protein.

They found that amphotericin restored pH levels, improved viscosity, and increased antibacterial activity.

Amphotericin also can be delivered directly to the lungs to avoid common adverse effects, the researchers say. Although more studies are needed, according to the National Institute of Health, “experts are hopeful.”

In cystic fibrosis (CF), a defective gene makes a defective protein that causes acidic and sticky mucus that clogs the lungs and puts patients at risk for bacterial infections. Because different people have different protein mutations, and 10% of patients with CF make no protein at all, treatments are limited. But amphotericin apparently has the potential to work regardless of the mutation and even when the protein is missing. The researchers liken it to a “molecular prosthetic,” because it restores function much as a prosthetic device replaces a limb.

In the study, supported in part by the National Heart, Lung, and Blood Institute, researchers used lung tissue from patients with CF as well as animal models. Instead of trying to correct the protein or do gene therapy, which the researchers say is not yet effective in the lung, they used a small molecule protein that can perform the channel function of the missing or defective protein.

They found that amphotericin restored pH levels, improved viscosity, and increased antibacterial activity.

Amphotericin also can be delivered directly to the lungs to avoid common adverse effects, the researchers say. Although more studies are needed, according to the National Institute of Health, “experts are hopeful.”

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Study Provides Insight Into Alcohol’s Effects on the Brain

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“Brain power” takes on new meaning with results from a study funded by the National Institute on Alcohol Abuse and Alcoholism.

The findings could lead the way to understanding the brain’s intake and output of energy in good health and bad and the part that alcohol plays.

In previous studies, the researchers have shown that alcohol significantly affects brain glucose metabolism, a measure of energy use, as well as regional brain activity, assessed through changes in blood oxygenation. But regional differences in glucose metabolism are hard to interpret, they say. In a study with healthy volunteers, they used brain imaging techniques to help quantify “match and mismatch” in energy consumption and expenditure across the brain—what they termed power and cost.

The researchers assessed power by observing to what extent brain regions are active and use energy, and cost by observing how brain regions expended energy. They found that different brain regions that serve distinct functions have “notably different power and different cost.”

Next, they tested a group of light drinkers and heavy drinkers and found both acute and chronic exposure to alcohol affected power and cost. In heavy drinkers, the researchers say, they saw less regional power, for example, in the thalamus, the sensory gateway, and frontal cortex. The researchers interpreted the decreases in power as reflecting the toxic effects of long-term exposure to alcohol on the brain cells.

They also found power dropped in the visual regions during acute alcohol exposure, which was related to disruption of visual processing. Visual regions also had the most significant drops in cost of activity during intoxication. That is consistent with the reliance of those regions on alternative energy sources, such as acetate (a byproduct of alcohol metabolism), the researchers say.

Their approach for characterizing brain energetic patterns related to alcohol use could be useful in other ways, the researchers say. “Studying energetic signatures of brain regions in different neuropsychiatric diseases is an important future direction,” said co-lead investigator Dr. Ehsan Schokri-Kojori. “The measures of power and cost may provide new multimodal biomarkers.”

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“Brain power” takes on new meaning with results from a study funded by the National Institute on Alcohol Abuse and Alcoholism.
“Brain power” takes on new meaning with results from a study funded by the National Institute on Alcohol Abuse and Alcoholism.

The findings could lead the way to understanding the brain’s intake and output of energy in good health and bad and the part that alcohol plays.

In previous studies, the researchers have shown that alcohol significantly affects brain glucose metabolism, a measure of energy use, as well as regional brain activity, assessed through changes in blood oxygenation. But regional differences in glucose metabolism are hard to interpret, they say. In a study with healthy volunteers, they used brain imaging techniques to help quantify “match and mismatch” in energy consumption and expenditure across the brain—what they termed power and cost.

The researchers assessed power by observing to what extent brain regions are active and use energy, and cost by observing how brain regions expended energy. They found that different brain regions that serve distinct functions have “notably different power and different cost.”

Next, they tested a group of light drinkers and heavy drinkers and found both acute and chronic exposure to alcohol affected power and cost. In heavy drinkers, the researchers say, they saw less regional power, for example, in the thalamus, the sensory gateway, and frontal cortex. The researchers interpreted the decreases in power as reflecting the toxic effects of long-term exposure to alcohol on the brain cells.

They also found power dropped in the visual regions during acute alcohol exposure, which was related to disruption of visual processing. Visual regions also had the most significant drops in cost of activity during intoxication. That is consistent with the reliance of those regions on alternative energy sources, such as acetate (a byproduct of alcohol metabolism), the researchers say.

Their approach for characterizing brain energetic patterns related to alcohol use could be useful in other ways, the researchers say. “Studying energetic signatures of brain regions in different neuropsychiatric diseases is an important future direction,” said co-lead investigator Dr. Ehsan Schokri-Kojori. “The measures of power and cost may provide new multimodal biomarkers.”

The findings could lead the way to understanding the brain’s intake and output of energy in good health and bad and the part that alcohol plays.

In previous studies, the researchers have shown that alcohol significantly affects brain glucose metabolism, a measure of energy use, as well as regional brain activity, assessed through changes in blood oxygenation. But regional differences in glucose metabolism are hard to interpret, they say. In a study with healthy volunteers, they used brain imaging techniques to help quantify “match and mismatch” in energy consumption and expenditure across the brain—what they termed power and cost.

The researchers assessed power by observing to what extent brain regions are active and use energy, and cost by observing how brain regions expended energy. They found that different brain regions that serve distinct functions have “notably different power and different cost.”

Next, they tested a group of light drinkers and heavy drinkers and found both acute and chronic exposure to alcohol affected power and cost. In heavy drinkers, the researchers say, they saw less regional power, for example, in the thalamus, the sensory gateway, and frontal cortex. The researchers interpreted the decreases in power as reflecting the toxic effects of long-term exposure to alcohol on the brain cells.

They also found power dropped in the visual regions during acute alcohol exposure, which was related to disruption of visual processing. Visual regions also had the most significant drops in cost of activity during intoxication. That is consistent with the reliance of those regions on alternative energy sources, such as acetate (a byproduct of alcohol metabolism), the researchers say.

Their approach for characterizing brain energetic patterns related to alcohol use could be useful in other ways, the researchers say. “Studying energetic signatures of brain regions in different neuropsychiatric diseases is an important future direction,” said co-lead investigator Dr. Ehsan Schokri-Kojori. “The measures of power and cost may provide new multimodal biomarkers.”

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